131
Participants
Start Date
May 12, 2017
Primary Completion Date
August 27, 2020
Study Completion Date
August 27, 2020
FlorenceM (US) and FlorenceX (UK)
"The automated closed loop system (FlorenceM in US) will consist of:~Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Guardian3 CGM and glucose suspend feature.~The automated closed loop system (FlorenceX in UK) will consist of:~The DANA Diabecare R insulin pump (Sooil Development, Korea) incorporating the Dexcom G6 CGM.~An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device."
Insulin pump therapy
Subjects will continue using their own insulin pump for 6 months.
Nemours Children's Health System, Jacksonville
Indiana University, Indianapolis
University of Colorado Denver School of Medicine Barbara Davis Center, Aurora
Stanford University, Palo Alto
Yale University, Hartford
University of Cambridge, Cambridge
Nottingham Children's Hospital, Nottingham
Southampton Children's Hospital, Southampton
The Leeds Teaching Hospitals NHS Trust, Leeds
Alder Hey Children's NHS Foundation Trust, Liverpool
Oxford Children's Hospital, Oxford
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Cambridge University Hospitals NHS Foundation Trust
OTHER
University of Colorado, Denver
OTHER
Indiana University
OTHER
The Leeds Teaching Hospitals NHS Trust
OTHER
Stanford University
OTHER
Yale University
OTHER
Nemours Children's Health System
OTHER
Jaeb Center for Health Research
OTHER